—#210294

Product

Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

FDA product code: MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K231328
Affected lot / code info: GTIN 00802526618215, Versions 2.0.101, 2.0.110

Why it was recalled

Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

A field action/communication with Health Care Providers (HCPs) for affected patients was initiated on September 6, 2024, to inform them of the issue and provide the necessary patient data and connection support. Clinicians and patients were contacted via telephone calls. The BSC RhythmCARE team first called clinicians to describe the monitoring problem. With permission of the clinician, RhythmCARE Support contacted the patient to request a patient-initiated interrogation of the insertable cardiac monitor. Next, they offered options to troubleshoot and resolve the monitoring problem. In most cases, the troubleshooting included providing a BSC provided mobile monitor, in a singular case, the patients chose to buy a new mobile phone. The goal of these troubleshooting calls was to re-establish patient monitoring as scheduled. Recommendations were provided on an individual basis

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.

Timeline

Recall initiated: 2024-09-06
Posted by FDA: 2024-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.